Accelerating the evaluation and monitoring of new medical products
Research Triangle Center of Excellence in Regulatory Science and Innovation
This study is working to make sure new medical technologies and treatments are tested and monitored better, so patients can get safe and effective products more quickly.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Univ of North Carolina Chapel Hill NIH-funded |
| Lab location | 1 site (Chapel Hill, United States) |
| Project ID | NIH-10877009 on NIH RePORTER |
What this research studies
This research focuses on improving the evaluation and monitoring processes for innovative medical technologies and therapeutics regulated by the FDA. By establishing the Research Triangle Center of Excellence in Regulatory Science and Innovation, the project aims to create a collaborative environment among universities and regulatory bodies to enhance methodologies for pre-market evaluation and post-marketing surveillance. The initiative will leverage advanced statistical methods, machine learning, and other innovative approaches to address existing gaps in regulatory science. Patients may benefit from more effective and timely access to safe and effective medical products as a result of this work.
Who could benefit from this research
Good fit: Ideal candidates for participation or benefit from this research include patients who are involved in clinical trials or those affected by conditions that may be treated with new FDA-regulated products.
Not a fit: Patients who are not involved in clinical trials or who do not require new medical technologies may not receive direct benefits from this research.
Why it matters
Potential benefit: If successful, this research could lead to faster and safer access to innovative medical products for patients.
How similar studies have performed: Other research initiatives have shown success in improving regulatory science methodologies, indicating that this approach has potential for impactful outcomes.
Where this research is happening
Chapel Hill, United States
- Univ of North Carolina Chapel Hill — Chapel Hill, United States (Active)
Researchers
- Principal investigator: Watkins, Paul B — Univ of North Carolina Chapel Hill
- Study coordinator: Watkins, Paul B
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.